The way abacavir (ABC) behaves in the body differs between children and adults, but little is known about ABC in adolescents. It is unclear if adult doses of ABC are appropriate for adolescents. The purpose of this study is to determine the blood levels of ABC in HIV infected adolescents who are on ABC-containing regimens.

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment:

30

Study Start Date:

July 2004

Study Completion Date:

December 2004

Detailed Description:

ABC is approved for the treatment of HIV in adults and children, but it is unclear if currently recommended ABC doses are appropriate for adolescents. Previous data suggest ABC clearance in children is about twice that found in adults, but limited data exist on the pharmacokinetics of ABC in adolescents. This study will evaluate the 8-hour pharmacokinetics of ABC in HIV infected adolescents who are currently on ABC-containing treatment regimens.

There will be two groups in this study. Group 1 participants will be 13 to 17 years old. Group 2 participants will be 18 to 25 years old. All participants will receive a 300 mg dose of ABC as either a single-agent tablet or a combination tablet of ABC, lamivudine, and zidovudine (whichever they are currently taking). Participants will have a medical history assessment and a physical exam at screening and study entry. Participants will also be asked about adherence to their ABC-containing regimen at study entry. During the 8-hour drug level study, blood collection for pharmacokinetic analysis will occur prior to taking ABC, and at 0.5, 1, 2, 3, 4, 6, and 8 hours after taking ABC.

Eligibility

Ages Eligible for Study:

13 Years to 25 Years (Child, Adult)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

HIV-1 infected

CD4 count greater than 100 cells/mm3

Viral load less than 100,000 copies/ml

Have taken an abacavir-containing regimen for at least 8 weeks prior to study entry

Any clinically significant disease other than HIV-1 infection that, in the investigator's opinion, would represent an increased risk for the participant or compromise the outcome of the study

Chemotherapy for active cancer

Pregnancy or breastfeeding

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087945

Locations

United States, California

Usc La Nichd Crs

Alhambra, California, United States, 91803

Children's Hospital of Los Angeles NICHD CRS

Los Angeles, California, United States, 90027

UCSD Mother-Child-Adolescent Program CRS

San Diego, California, United States, 92103

United States, District of Columbia

Children's National Med. Ctr. Washington DC NICHD CRS

Washington, District of Columbia, United States, 20010

Children's National Med. Ctr., ACTU

Washington, District of Columbia, United States, 20010

United States, Florida

Univ. of Florida Jacksonville NICHD CRS

Jacksonville, Florida, United States, 32209

USF - Tampa NICHD CRS

Tampa, Florida, United States, 33606

United States, Georgia

Med. College of Georgia School of Medicine, Dept. of Peds., Div. of Infectious Diseases